Healthy Body Services
⚠️ Moderate Risk
FEI: 3002721927 • North York, Ontario • CANADA
FEI Number
3002721927
Location
North York, Ontario
Country
CANADAAddress
509-4576 Yonge St, , North York, Ontario, Canada
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
UNSAFE ADD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/17/2023 | 54YCR11WHEY PROTEIN POWDER (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | 260FALSE | Division of Northern Border Imports (DNBI) |
| 8/27/2013 | 66BAY05CAFFEINE (STIMULANT) | Detroit District Office (DET-DO) | |
| 8/27/2013 | 66BAY05CAFFEINE (STIMULANT) | Detroit District Office (DET-DO) | |
| 8/27/2013 | 66BAY05CAFFEINE (STIMULANT) | Detroit District Office (DET-DO) | |
| 3/27/2009 | 54CAR99PROTEIN N.E.C. | 482NUTRIT LBL | New York District Office (NYK-DO) |
| 10/21/2006 | 41BYT99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS | 238UNSAFE ADD | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Healthy Body Services's FDA import refusal history?
Healthy Body Services (FEI: 3002721927) has 6 FDA import refusal record(s) in our database, spanning from 10/21/2006 to 2/17/2023.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Healthy Body Services's FEI number is 3002721927.
What types of violations has Healthy Body Services received?
Healthy Body Services has been cited for 7 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Healthy Body Services come from?
All FDA import refusal data for Healthy Body Services is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.